鲎试剂法用于脑复素注射液细菌内毒素检测条件探索

To Inspect the Bacterium Endotoxin in Cerebroprotein Hydrolysate Injection with the Tachytleus Amebecyte Lysate

本文采用增强或抑制试验,对本厂生产的脑复素注射液进行了细菌内毒素检测考察。按照中华人民共和国药典“细菌内毒素检查法”操作,采用鲎试剂与细菌内毒素的凝集试验。根据三批样品实验结果表明,脑复素80倍稀释液对灵敏度为0.125Eu/ml 的鲎试剂无增强或抑制作用,故本品适合用鲎试剂作内毒素检查。

We adopt to strengthen or control tests to inspect the bacterium endotoxin in Cerebroprotein Hydrolysate injection.According to the method of inspection that the bacterium endotoxin in the pharmacopoeia of the People's Republic of China,We adopt that tachytleus ame- becyte lysate and bacterium endotoxin agglutinate experiment.According to 3 tests,We know that 80 times dilution meterings can't strengthen or control sensitivity of 0.125Eu/ml tachytleusAmeboyte lysate.So it can be inspected with the about bacterium endotoxin.